Read the Patient Information Leaflet available from your pharmacist before you start using miconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication by mouth as directed by your doctor, usually once daily in the morning, after brushing your teeth. Before applying the tablet, locate the area in your mouth at which to place the tablet. It should be placed at the upper gum, just above the left or right incisor tooth. The incisors are the teeth just to the left and right of your two front teeth. With dry hands, place one tablet in your mouth with the round side facing against your gum and gently push it into place. Remove your hand from inside your mouth and apply a slight pressure with your finger on the outside of your upper lip for 30 seconds. This will make the tablet stick to your gum. Leave the tablet in place until it is dissolved (usually 6 hours or longer). You may eat and drink while using this medication. Do not crush, chew or swallow the tablet. Check if the tablet is still in place after you brush your teeth, rinse your mouth, eat, or drink. Before applying the next dose, clear away any remaining tablet pieces. Change sides of the mouth with each dose.

It is okay if the tablet sticks to your gum, or to the inside of your lip or cheek. If it does not stick or if it falls off your gum within the first 6 hours, apply it again as directed. If it still does not stick, replace it with a new tablet. If you accidentally swallow the tablet within the first 6 hours after placement, drink a glass of water and apply a new dose to your gum.

If it is 6 hours or longer after placement and the tablet falls off or is accidentally swallowed, do not apply a new dose. Just use your next dose at your usual time.

Avoid activities that may prevent the buccal tablet from sticking to your gum, including touching or pressing the tablet after placement, wearing an upper denture that interferes with tablet placement, chewing gum, hitting the tablet when brushing your teeth, or rinsing your mouth too forcefully.

Antifungals work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.

Continue to use this medication until the full prescribed amount is finished (usually 14 days), even if symptoms disappear after a few days. Stopping the medication too early may allow fungus to continue to grow, which may result in a return of the infection.

Discomfort, sores, taste changes, or irritation/pain in the mouth may occur. Nausea, vomiting, diarrhea, abdominal pain, or headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

rash

itching/swelling (especially of the face/tongue/throat)

severe dizziness

trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using miconazole buccal tablets, tell your doctor or pharmacist if you are allergic to miconazole; or if you have any other allergies. This product may contain inactive ingredients (such as milk protein concentrate), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include:

warfarin

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Store at room temperature away from moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised June 2018.

Copyright(c) 2018 First Databank, Inc.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.